Upcoming workshop to provide an introduction to animal health regulatory affairs

Thursday, Feb. 13, 2020

OLATHE — Kansas State University's Olathe campus is once again offering its popular "Animal Health Regulatory 101" workshop.

This two-day workshop serves as an introductory course about the regulatory aspects of animal drug and vaccine development. The workshop is from 8:30 a.m. to 4:30 p.m. June 17-18 at K-State's Olathe campus.

During the course, attendees will take a deep-dive into the regulatory aspects around animal drug and vaccine development. They also will learn how to navigate two of the federal agencies that oversee these products.

Content is designed for professionals who are tasked with developing and maintaining an animal health company's product portfolio and who are involved with the company's regulatory strategies. This includes professionals at contract research organizations, contract development and manufacturing organizations, entrepreneurs, regulatory agents, U.S. agents of foreign corporations, process owners, record retention specialists, financial and institutional advisors, and professionals who are new to the animal health industry.

The workshop is divided into seven broad sections that cover the regulatory spectrum. Section topics include an introduction and overview to the regulatory process; the approval process; fees and waivers; and how the U.S. Food and Drug Administration and the U.S. Department of Agriculture regulate animal health products.

The workshop is led by Rob Hunter, Ph.D., and Norm Brown. They have 55 years of combined experience in the animal health regulatory affairs field at several high-profile companies, such as Pfizer Inc., Elanco Animal Health Inc., Boehringer-Ingelheim Animal Health and Merck Animal Health.

"We received strong interest and a lot of positive feedback about the previous 'Animal Health Regulatory 101' workshop, so it made sense to offer it again to those who were unable to attend," said Angela Buzard, manager of training and development at K-State's Olathe campus. "Moreover, it extends our support of the animal health regulatory affairs industry, which the university and our campus are actively engaged in."

The previous "Animal Health Regulatory 101" workshop, which was conducted in November 2019, had 24 participants from 12 animal health companies. At the end of the second day, participants were asked to evaluate the information and experience they were presented. Overall evaluation scores were a 4.48 on a 5.0 scale.

Similarly, Buzard received comments from leadership at several companies that sent employees. One stated that their employee "raved" about the drug development process overview and the course's instructor.

Multiple participants and companies also said they would like separate, follow-up courses for the USDA and FDA. These separate courses currently are being developed and will be held later this year, Buzard said.

Registration and more information are at olathe.k-state.edu/regaffairs101.

Please note that the original date listed was April 1-2. The date was changed in response to COVID-19.